Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Registration of a class III or IV medical device

Brazil · Brazilian Health Regulatory Agency · Medical devices

Device: registration or licence with the regulatorHigh confidenceLast verified October 3, 2026

Review target

320 days

regulation

Legal time limit

Not published

Steps

9 requirements

What is the Registration of a class III or IV medical device in Brazil?

High and maximum risk devices (classes III and IV) need registration after a technical review of the dossier. Approval also waits for an Anvisa GMP certificate. The response targets are 250 days for equipment and software and 320 days for medical materials. Registration lasts 10 years. Medical devices in class III or IV, including devices that contain a medicinal substance with an ancillary action, which are class IV.

How long does the Registration of a class III or IV medical device take?

The official review target is 320 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.

How much does the Registration of a class III or IV medical device cost?

The registration fee, large diagnostic or therapy equipment (for example mri, ct, nuclear medicine) is R$39,048 for Fee table in force when checked (2026-10-03). A reduced fee of R$3,905 applies in some cases (Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 1,952.40).

What are the steps of the Registration of a class III or IV medical device?

1. File registration and pay fee; 2. Technical review; 3. Additional documents requested (clock stopped); 4. GMP certificate published; 5. Registration published.

Outcome: Registration published in the Official Gazette, valid for 10 years and renewable. Valid for 10 years.

Legal basis: Lei 6.360/1976 (Art. 12 and Art. 25); Anvisa RDC 751/2022

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 320 days end to end with the official step targets. Targets, not actual times.

Approvals per year, device: registration or licence with the regulator in Brazil

From the official approvals data of this market, all products of this pathway type and segment

Steps

In order, with the official target for each step

1. File registration and pay feeForm, technical dossier, manufacturer declaration and foreign registration or free sale proof for imports, GMP certificate or proof of the certification request.
2. Technical reviewup to 320 daysThe response target is 250 days for equipment and software and 320 days for materials.
3. Additional documents requested (clock stopped)clock stopped, only in some casesIncomplete petitions can be refused without a technical requirement.
4. GMP certificate publishedThe registration is granted only after a valid Anvisa GMP certificate is published.
5. Registration publishedPublished in the Official Gazette.

Requirements

What the applicant must provide or meet

Other

Dossier format: technical dossier by risk classDescription, intended use, warnings, presentations, labels and instructions, manufacturing flow and a description of safety and performance under the essential requirements, organized by risk class.

Clinical evaluation

Clinical evidence(in some cases)Safety and performance are shown against applicable technical standards. Products with innovative technology or indications need clinical evidence, and Anvisa can ask for a clinical study report.

Inspection

Anvisa GMP certificateApproval depends on publication of a valid Anvisa GMP certificate.

Reference approval

Proof of registration or free sale abroad(in some cases)For imported devices, a registration certificate, free sale certificate or equivalent from the country of manufacture or sale, no older than two years.

Eligibility

Devices with a medicinal substance(in some cases)Devices that include a substance that would be a medicine on its own, with an ancillary action, are class IV.

Local presence

Brazilian holder (maker or importer)The notification or registration holder is a company in Brazil, the manufacturer or importer, responsible for the device in the country. For imported devices, the foreign legal manufacturer gives a legalized declaration, no older than two years, authorizing the company to represent and sell its products in Brazil.

Language

Portuguese labeling and instructionsPetition forms, instructions for use and labels must be in Portuguese. Other documents may be in Portuguese, Spanish or English.

Labeling

Instructions for use uploaded to the agency repositoryThe holder uploads the instructions for use within 30 days after publication.

After approval

Technovigilance reportingDeaths, serious threats to public health and counterfeits in Brazil are reported within 72 hours; serious adverse events without death within 10 calendar days.

Official time targets

Targets, not actual review times

Decisionregulation. Equipment and medical software registrations.	250 days
Review targetregulation. Medical materials. The target for equipment and software is 250 days. Targets are official response times, not observed times.	320 days

Fees

Official amounts in the local currency

Fee	Amount
Registration fee, large diagnostic or therapy equipment (for example MRI, CT, nuclear medicine)Application · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 1,952.40.	R$39,048reduced R$3,905
Registration fee, medium and small equipment, materials, IVDs and other health productsApplication · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 780.96.	R$15,619reduced R$1,562

Fee

Amount

Registration fee, large diagnostic or therapy equipment (for example MRI, CT, nuclear medicine)Application · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 1,952.40.

R$39,048reduced R$3,905

Registration fee, medium and small equipment, materials, IVDs and other health productsApplication · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 780.96.

R$15,619reduced R$1,562